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Prevention study for Vasovagal Syncope
Official title Study of Atomoxetine in the Prevention of Vasovagal Syncope
ClinicalTrials.gov ID: NCT05159687
What this study is testing
What is Atomoxetine Hydrochloride?
Atomoxetine Hydrochloride is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for vasovagal syncope.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Project rationale: Vasovagal syncope (VVS) affects up to 50% of people, and recurrent syncope markedly reduces quality of life. We recently reported that it is frequently associated with injury and not surprisingly with clinical anxiety.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Syncope according to the American College of Cardiology Guidelines 2017
- At least 2 vasovagal syncope spells in the preceding 12 months
- At least -2 on the Syncope Symptom Score for Structurally Normal Hearts
- At least 18 years old with informed consent
You likely can't join if
- Other cause of syncope
- A 5-minute stand test resulting in the diagnosis Orthostatic Hypotension or Postural Orthostatic Tachycardia Syndrome
- An inability to give informed consent
- Pregnant
- Unwilling or unable to use adequate birth control while on study drug.
- An important valvular, coronary, myocardial, or conduction abnormality, or significant arrhythmia
See the full eligibility criteria
- Syncope according to the American College of Cardiology Guidelines 2017
- At least 2 vasovagal syncope spells in the preceding 12 months
- At least -2 on the Syncope Symptom Score for Structurally Normal Hearts
- At least 18 years old with informed consent
- Other cause of syncope
- A 5-minute stand test resulting in the diagnosis Orthostatic Hypotension or Postural Orthostatic Tachycardia Syndrome
- An inability to give informed consent
- Pregnant
- Unwilling or unable to use adequate birth control while on study drug.
- An important valvular, coronary, myocardial, or conduction abnormality, or significant arrhythmia
- Uncontrolled hypertension
- Uncontrolled hyperthyroidism
- A permanent pacemaker
- Taking or has recently taken a monoamine oxidase inhibitor
- Pheochromocytoma
- Glaucoma
- Prior use of atomoxetine for syncope
- Clinical need for atomoxetine or another potent norepinephrine transporter inhibitors (Ki NET \ 10 Ki atomoxetine),
- Current use of β-blocker, bupropion, α1-adrenergic agonists or antagonists, tricyclic antidepressants, serotonin reuptake inhibitors, scopolamine, theophylline, or fludrocortisone.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.